What does this research mean for the field?

Dedicated transcatheter aortic valve replacement devices provide superior device success and significantly reduce valve migration and mortality compared to conventional devices in patients with pure native aortic regurgitation. Novelty: ClaimNovelty.SYNTHESIS. Consensus alignment: ConsensusAlignment.NEUTRAL.

October 28, 2025Journal of the American Heart AssociationOpen Access

Dedicated Versus Conventional Devices in Patients With Pure Native Aortic Regurgitation: A Systematic Review and Meta‐Analysis

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Why the study?

Many patients with pure native aortic regurgitation have unacceptable surgical risk, and this meta-analysis aims to evaluate transcatheter aortic valve replacement efficacy in this setting.

Does transcatheter aortic valve replacement (TAVR) using dedicated devices improve clinical outcomes and procedural success in patients with pure native aortic regurgitation unsuitable for surgery?

Structured PICO

Does transcatheter aortic valve replacement (TAVR) using dedicated devices improve clinical outcomes and procedural success in patients with pure native aortic regurgitation unsuitable for surgery?

Population

1,804 adult patients with predominantly pure native aortic regurgitation (PNAR) unsuitable for surgical replacement or repair, pooled from 19 observational studies. Mean age 75.3 years, male:female ratio 0.58, mean STS-PROM 6.5%.

Intervention

Transcatheter aortic valve replacement (TAVR) as a class, specifically analyzing and comparing dedicated devices, second-generation devices, and first-generation devices.

Comparator

Comparison between different generations of TAVR devices (first-generation vs. second-generation vs. dedicated devices).

Outcome

30-day all-cause mortalityhard clinical

In patients with pure native aortic regurgitation who are at high risk for surgery, TAVR using dedicated devices is associated with higher procedural success and lower short-term mortality compared to older generation devices.

Limitations

observational design
lack of patient-level data
device heterogeneity
potential publication bias

Implication

Dedicated devices warrant preference in high-risk pure native AR TAVR; confirms mortality benefit over early-generation devices.

Abstract

Background Surgical aortic valve replacement is the gold standard for treating pure native aortic regurgitation. However, many patients have unacceptable surgical risk. Increasing evidence supports the use of transcatheter aortic valve replacement in this subset. This metanalysis aims to evaluate transcatheter aortic valve replacement efficacy in pure native aortic regurgitation. Methods We systematically searched MEDLINE/PubMed, Embase, the Cochrane Database, Google Scholar, ClinicalTrials.gov , and major cardiology conference abstracts from inception to April 1, 2024, and included 19 observational studies with ≥20 patients with pure native aortic regurgitation undergoing transcatheter aortic valve replacement. The primary end point was 30‐day all‐cause mortality; secondary end points were device success, valve migration, and 1‐year all‐cause mortality. Pooled estimates were calculated using random‐effects meta‐analysis. Risk of bias was assessed using the Newcastle–Ottawa Scale and publication bias with funnel plots and Egger’s test. The study protocol was registered in International Prospective Register of Systematic Reviews (CRD42024534117). Results The pooled 30‐day mortality was 8.7% (95% CI, 5.8%–10.7%), and decreased from first (16.9% [95% CI, 13.2%–18.9%]) to second generation (7.2% [95% CI, 6.1%–9.2%]) and dedicated devices (4.7% [95% CI, 1.8%–8.9%; P <0.0001]). Overall device success was 84.1% (95% CI, 78.0%–88.9%), improving from first (63.1% [95% CI, 52.0%–72.5%]) to second generation (86.3% [95% CI, 80.1%–90.4%]) and dedicated devices (93.0% [95% CI, 86.2%–97.3%]; P <0.00001). Valve migration occurred in 7.8% (95% CI, 5.0%–11.7%) of cases, decreasing from first (19.0% [95% CI, 15.2%–24.7%]) to second generation (6.9% [95% CI, 3.7%–10.0%]) and dedicated devices (3.0% [95% CI, 1.3%–5.6%]; P <0.00001). Overall 1‐year mortality was 14.0% (95% CI, 10.1%–19.9%) and decreased from first (27.2% [95% CI, 15.4%–43.2%]) to second generation (12.7% [95% CI, 8.8%–18.9%]) and dedicated devices (8.7% [95% CI, 3.5%–16.7%]; P <0.0001). Conclusions Although the observational design, lack of patient‐level data, device heterogeneity, and potential publication bias limit definitive conclusions, transcatheter aortic valve replacement using dedicated devices may be considered a safe and effective therapeutic option for patients with pure native aortic regurgitation and unacceptable risk for surgery. Registration URL: https://www.crd.york.ac.uk/prospero/ ; Unique identifier: CRD42024534117.